483
Donald J Garcia, Jr. M.D.FDA 483 - Donald J Garcia, Jr. M.D. - October 11, 2024
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
Record Details
Donald J Garcia, Jr. M.D., a clinical investigator in Austin, TX, was cited by the FDA for failing to maintain accurate case histories during an inspection. The firm incorrectly transcribed CAPS5 data into electronic case report forms (eCRF), leading to discrepancies between source data and data submitted to the FDA. This indicates significant issues with data integrity and record-keeping practices.
- Office
- Dallas District Office
- Person
Open in Dashboard
ID · c09e518f-6f2f-442b-9c2c-4b6e2795bf19